IP Library Granted Patent US 10,908,093
Granted Patent B2
US 10,908,093 · App. 14/867,271 · Granted Feb 2, 2021

Calibration of fluidic devices

Inventors: Ian Gibbons (Newark, CA); Chengwang Wang (Palo Alto, CA); Shaunak Roy (Palo Alto, CA); Elizabeth A. Holmes (Palo Alto, CA)
Assignee: Labrador Diagnostics, LLC
G01N21/76A61B5/1411A61B5/1427A61B5/14532A61B5/157A61B5/15142A61B5/412A61B5/417B01L3/50273G01N33/50G01N33/53G01N33/5302G01N33/54386G16H40/63A61B5/1495A61B5/14546A61B5/150022A61B5/150099A61B5/150251A61B5/150763A61B5/150854B01L2300/021B01L2300/023B01L2300/044B01L2300/0636B01L2300/087B01L2300/0816B01L2300/0867B01L2300/0877B01L2300/0883B01L2300/0887G01N2500/00Y02A90/10Y10T436/10Y10T436/11Y10T436/115831Y10T436/12Y10T436/143333
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,908,093
App. No.
14/867,271
Granted
Feb 2, 2021
Kind
B2
Abstract

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

Claims (24)

1. A method comprising:

inserting a cartridge into a reader assembly, the reader assembly comprising a processor, an analyte signal detector, and a communication interface, the cartridge being configured to be coupled to the reader assembly, the cartridge comprising:

i) a structure configured to receive a sample;

ii) a reactant capable of reacting with a biological analyte in the sample; and

iii) an information storage unit storing identifier information identifying the cartridge;

obtaining the identifier information from the information storage unit;

transmitting the identifier information to a computer server, prior to performing an assay using the cartridge coupled to the reader assembly;

in response to receiving the identifier information, the computer server using the received identifier information to select a protocol from a plurality of protocols stored in the computer server, the selected protocol then being transmitted electronically by the computer server to the communication interface of the reader assembly, wherein the selected protocol comprises instructions to the processor to perform the assay using the cartridge;

measuring with the analyte signal detector, in accordance with the selected protocol, a first signal produced by a first assay of the sample, wherein the sample comprises a known quantity of the biological analyte;

measuring a second signal produced by a second assay of the sample after spiking the sample with a known quantity of the biological analyte;

plotting the difference between said first and second signals against an expected signal representing a target value, wherein the target value is a value expected for the known quantity of the biological analyte;

computing a best fit of calibration parameters by minimizing the sum of the square of the differences between the target value and calculated analyte values from the first and second signals; and

updating a factory calibration parameter of the reader assembly.

2. The method of claim 1 , wherein the communication interface is configured to receive the selected protocol wirelessly from the computer server.

3. The method of claim 1 , wherein the communication interface is configured to receive the protocol via a wired connection from the computer server.

4. The method of claim 1 , further comprising measuring a third signal from the cartridge representative of a presence or non-presence of the biological analyte present in a second sample based a selected protocol received from the computer server.

5. The method of claim 4 , wherein the analyte signal detector is configured to detect a luminescent signal.

6. The method of claim 4 , wherein the analyte signal detector is configured to detect a chemiluminescent signal.

7. The method of claim 4 , the cartridge further comprising a first layer and a second layer, wherein the first and second layers are assembled to form a three dimensional fluidic channel network.

8. The method of claim 4 , further comprising:

detecting, via the analyte signal detector, the third signal from the cartridge representative of a presence or non-presence of a biological analyte present in a reaction site based a selected protocol received from the computer server; and

correcting a second calibration parameter in response to the third signal.

9. The method of claim 8 , further comprising:

compensating temperature control parameters in response to the correcting of the further calibration parameter prior to detecting via the analyte signal detector, the second signal from the cartridge representative of a presence or non-presence of a biological analyte present in in the second sample based on a selected protocol received from the computer server.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: GOLDEN DIAGNOSTICS TOP CORP.
To: GOLDEN DIAGNOSTICS CORP.
Reel/Frame 064264/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: LABRADOR DIAGNOSTICS LLC
To: GOLDEN DIAGNOSTICS TOP CORP.
Reel/Frame 064262/0539 →
CHANGE OF NAME Recorded Apr 7, 2020
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052329/0716 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045075/0310 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2017
From: GIBBONS, IAN; WANG, CHENGWANG; ROY, SHAUNAK; HOLMES, ELIZABETH A.
To: THERANOS, INC.
Reel/Frame 042361/0006 →
Continuity (7)
Continuation 12986954 · Jan 7, 2011
Continuation 11388824 · Mar 24, 2006
Provisional Application 60678801 · May 9, 2005
Provisional Application 60705489 · Aug 5, 2005
Provisional Application 60717192 · Sep 16, 2005
Provisional Application 60721097 · Sep 28, 2005
Related Publication 20160116417A1 · Apr 28, 2016